A Study to Assess Overall Survival and Treatment Patterns for Advanced Liver Cancer Participants Who Received Nivolumab Therapy

Hepatocellular Carcinoma Clinical Trial

Official title:

Overall Survival and Treatment Patterns for Advanced Hepatocellular Carcinoma Patients Who Received Second or Third Line Nivolumab Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161911
• Other study ID #: CA209-79L
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: November 19, 2018

Study information

• Verified date: November 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A study to describe real-world treatment patterns and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy

Description:

The central aims of this study are descriptive and designed to describe the patient demographics, clinical characteristics, treatment patterns, and overall survival in advanced liver cancer participants who received second or third line nivolumab therapy in the real-world setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1426
• Est. completion date: November 19, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult aHCC participants in the Flatiron database as defined by:

• Diagnosed with HCC International Classification of Diseases (ICD)-9 155.x or ICD-10 C22.x)

• Pathology consistent with advanced HCC

• Age 18 years or older at index

• At least two clinic encounters on different days in the Flatiron database occurring on or after January 1, 2011

• Participants who received second or third line nivolumab monotherapy or combination therapy for aHCC

Exclusion Criteria:

• Participants with <1 month of medical data (any clinic visits, medication administrations or oral medication prescriptions) following and including the index date

• Participants with clinical study drug during prior or post study index periods

Other protocol-defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
United States	Bristol Myers Squibb, CORDS Research	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment patterns	Nivolumab second and third lines of therapy will be described including prior lines of therapy, duration of nivolumab therapy and time from aHCC diagnosis date to first nivolumab treatment	From aHCC diagnosis date to first nivolumab treatment (Up to 7.75 years)
Primary	Overall Survival	The initial second or third line nivolumab therapy date will be used as the start date for the OS analysis. Occurrence of death will be considered as event and the duration for event will be calculated as time from 2L or 3L nivolumab therapy date to death date. Patients who survived will be censored and their duration period will be the time between the initial 2L or 3L nivolumab therapy date and the last date of their post-period follow up	From start date of 2L and 3L nivolumab therapy to the date of death (Up to 7.75 years)

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form